The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and
maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The
expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in
patients with advanced metastatic melanoma.
Description: The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
Type: Drug
Primary Outcomes
Measure: Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733 Time: 12 months
Measure: Pharmacokinetic characterization of TAK-733 Time: 12 months
Secondary Outcomes
Measure: Effect of food on the pharmacokinetics of TAK-733 Time: 12 months
Measure: Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies Time: 12 months
Measure: Antitumor activity of TAK-733 in melanoma patients Time: 12 months